The FDA expanded Novartis’ radioligand therapy Pluvicto into an earlier stage of PSMA-positive prostate cancer by granting supplemental approval for patients with metastatic hormone-sensitive prostate cancer receiving an androgen receptor pathway inhibitor plus androgen deprivation therapy. The decision nearly doubles the eligible population relative to prior approvals limited to metastatic castration-resistant disease lines. Novartis’ application was supported by data from the PSMAddition program, where the Pluvicto regimen cut the risk of disease progression or death versus standard of care alone. The company also reported safety results aligned with Pluvicto’s established profile. With Pluvicto now spanning across metastatic prostate cancer stages where PSMA is present, the label expansion intensifies competition in nuclear medicine earlier in the treatment journey and increases demand for PSMA testing infrastructure.